Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006638824

FEI Number

3006638824

Entity Name

ETHICON, INC.

City/State/Country

CIUDAD JUAREZ Chihuahua, MX

Establishment Address

Calle Durango No. 2751, LOTE BRAVO, CIUDAD JUAREZ Chihuahua C.P. 32575, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ETHICON INC. (Owner Number: 2210968)

Owner / Operator Contact Address

1000 US Highway 202 S., Raritan, NJ 08869, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PROLENE on TEFLON Pledget Suture Buttress E-Z Clean electrosurgical electrodes DePuy Mitek - GRYPHON BR GRYPHON PEEK Mitek TIGHT-N Anchor Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Coated VICRYL Plus Antibacterial (polyglactin 910) Absorbable Suture STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device STRATAFIX Spiral PDS Plus Knotless Tissue Control Device STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device Cotton Umbilical Tape Electrosurgical Electrode DePuy Mitek - GRYPHON GRYPHON® P PEEK Anchor with DYNACORD GRYPHON® P BR DS Anchor with DYNACORD DePuy Mitek - GRYPHON® P BR Anchor with DYNACORD GRYPHON® P PEEK DS Anchor with DYNACORD PDS II (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture VICRYL (Polyglactin 910) Sterile Synthetic Absorbable Surgical Suture DePuy Mitek - Latarjet MERSILENE WHITE WOVEN Polyester Fiber Ligature MERSILENE Tape MERSILENE WHITE WOVEN Polyester Fiber Strip DePuy Mitek - GRYPHON DePuy Mitek - HEALIX BR PROLENE Polypropylene Nonabsorbable Suture DePuy Mitek - GRYPHON Flex Knotless PEEK and Biocomposite Anchors E-Z Clean Laparoscopic Electrode DePuy Mitek Instrument DePuy Mitek - ACORN Reamer Sterile (various sizes) DePuy Mitek - GRYPHON DePuy Mitek Instrument Mersilene Tape MERSILENE WHITE WOVEN Polyester Fiber Strip MERSILENE WHITE WOVEN Polyester Fiber Ligature Nylon Tape DePuy Mitek - IDEAL SUTGRASPER (various sizes) DePuy Mitek - Arthroscopic Instruments MONOCRYL (Dyed) Suture DePuy Mitek - FASTIN RC Modified Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture DePuy Mitek - Versalok Pre-packed W/Orthocord Depuy Mitek - VERSALOK DePuy Mitek - ORTHOCORD NEUWAVE Microwave Ablation System and Accessories MONOCRYL PLUS Antibacterial (Poliglecaprone 25) Suture Coated VICRYL Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture HIP STRAIGHT BLADE HIP CURVED BLADE, HIP ACCESS KIT CURVE BLADE, HIP ACCESS KIT NO BLADE HEALIX ADV 4.5 HARD BONE INST GUIDEWIRE 12 INCH STERILE 6PK 1.1 MM TROCAR TIP GUIDEWIRE DePuy Mitek Instrument 1.6MM GUIDEWIREETO ACL ACC DISPOSABLES KIT *EA ADJ. DISPOSABLESYSTEM CHIA PERCPASSER SUTURE PASSER 5 PACK GUIDEWIRE 12 INCH STERILE 1EA HIP ACCESS KIT STR BLADE PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture PDS II Suture DePuy Synthes - OUTSIDE-IN DISPOSABLE KIT DePuy Synthes - RIGIDLOOP DISPOSABLES SYSTM DePuy Mitek - Milagro Interference Screws DePuy Mitek - Milagro Advance Interference Screws DePuy Mitek - ORTHOCORD DePuy Mitek - Super Anchor - Orthocord DePuy Mitek - HEALIX ADVANCE DePuy Mitek - PROFILE DePuy Mitek - MILAGRO ADVANCE MITEK DRILL GUIDE DePuy Mitek - ABSOLUTE G-W NTNL 1.1MMX15" *PK/6 DePuy Mitek - MILAGRO BR DePuy Mitek - Truespan DePuy Mitek - DYNATAPE Suture PDS Plus Antibacterial Suture Lletz Loop Electrodes DePuy Synthes - Free Needle Loop OS-6 12PK DePuy Synthes - Free Needle Loop OS-6 1EA Surgical Stainless Steel Suture NEUWAVE Microwave Ablation System and Accessories DePuy Mitek - ORTHOCORD MegaTip ETHILON Blue Suture DePuy Mitek - MILAGRO BR DYNACORD Sutures (Blue, White/Blue/Green), with OS-6 needles. Multi (12) Pack DYNACORD Suture (White/Blue/Green), no needles. Single Pack DYNACORD Suture (White/Blue/Green), no needles. Multi (12) Pack DYNACORD Suture (Blue), with MO-7 needle. Multi (12) Pack DYNACORD Sutures (Blue, White/Blue/Green), with MO-7 needles. Single Pack DYNACORD Suture (Blue), no needles. Multi (12) Pack DYNACORD Sutures (Blue, White/Blue/Green), with OS-6 needles. Single Pack DYNACORD Suture (Blue), with OS-6 needle. Single Pack DYNACORD Sutures (Blue, White/Blue/Green), no needles. Single Pack DYNACORD Sutures (Blue, White/Blue/Green), with MO-7 needles. Multi (12) Pack DePuy Mitek - DYNACORD Suture (Blue), no needles. Single Pack DYNACORD Sutures (Blue, White/Blue/Green), no needles. Multi (12) Pack DYNACORD Suture (Blue), with OS-6 needle. Multi (12) Pack DYNACORD Suture (Blue), with MO-7 needle. Single Pack TFE Polymer Pledgets DePuy Mitek - HEALIX ADVANCE with DYNATAPE DePuy Mitek - RIGIDLOOP ADJUSTABLE DePuy Mitek - HEALIX ADVANCE KNOTLESS DePuy Mitek - HEALIX Ti Temporary Cardiac Pacing Wire Megadyne Laparoscopic Tubing Megadyne Speculum Tubing DePuy Mitek - GRYPHON PEEK DePuy Mitek - SPEEDTRAP DePuy Mitek - RIGIDFIX DePuy Mitek - HEALIX ADVANCE KNOTLESS SECURESTRAP Open Absorbable Strap Fixation Device DePuy Mitek - MINILOK DePuy Mitek - QUICKANCHOR DePuy Mitek - OMNISPAN DePuy Mitek - PERMALOOP Suture, PERMATAPE Suture DePuy Mitek - Healix Ti with DYNATAPE DePuy Mitek - Intrafix Advance PRONOVA Poly (Hexafluoropropylene - VDF) Suture DePuy Mitek - MILAGRO ADVANCE DePuy Mitek - RigidFix PLA DePuy Mitek - GII DePuy Mitek - ORTHOCORD MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture DePuy Mitek - BIOKNOTLESS DePuy Mitek - INTRAFIX DePuy Mitek - BIOKNOTLESS DePuy Mitek - LUPINE PDS Plus (Polydioxanone) Antibacterial Suture MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices DePuy Mitek - Healix Advance DePuy Mitek - HEALIX ADVANCE BR WITH PERMACORD HEALIX ADVANCE PEEK ANCHORS WITH PERMACORD DePuy Mitek - HEALIX PEEK DePuy Mitek - Healix Advance Knotless, Healix Advance Self-Punching DePuy Mitek - Healix Advance SP MILAGRO ADVANCE DePuy Mitek - MILAGRO BR DePuy Mitek - RIGIDLOOP DePuy Mitek - QUICKANCHOR MICROFIX QUICKANCHOR MICROFIX DePuy Mitek - HEALIX TRANSTEND PEEK HEALIX TRANSTEND HEALIX PEEK HEALIX BR DePuy Mitek - PERMATAPE DePuy Mitek - HEALIX ADVANCE PEEK COATED VICRYL SUTURE PERMA-HAND/Mersilk Suture/Silk Suture ETHILON Nylon Suture NUROLON ETHIBOND ETHIBOND EXCEL SURGICAL GUT SUTURE (Plain and Chromic) MERSILENE, MERSUTURE DePuy Mitek - ACL GRAFT KNIVES DePuy Mitek - COMBO BEATHPIN DePuy Mitek - 4.5 LONGER TIP BEATH PIN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2012-02-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-11-23
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-01-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2026-02-19
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2026-02-19
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-02-19
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2026-02-19
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2018-12-12
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2019-01-14
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2019-01-14
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	2014-04-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-11-10
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-24
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-24
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2020-01-02
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2020-01-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-24
HDH	Needle, Cerclage, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2016-07-21
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-23
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2013-12-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-19
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2025-06-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-11-10
HTO	Reamer	Orthopedic	Class 1	888.4540	2023-08-23
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-24
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-24
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	1991-12-20
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2023-08-23
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2008-03-20
GAN	Suture, Absorbable, Synthetic	General, Plastic Surgery	Class 2	878.4830	2008-03-20
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-23
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2011-12-15
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2023-08-23
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2023-08-24
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-08-24
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-22
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	1994-01-03
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2015-05-19
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-04-10
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2022-03-08
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2013-05-17
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	1992-10-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-04-11
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-04-11
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2012-12-18
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2012-12-18
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-23
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-24
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1993-11-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-24
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-24
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-08-24
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2025-11-24
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2021-11-10
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	1977-12-20
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2017-11-03
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2020-12-17
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2012-12-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-06-30
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2019-03-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-24
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-24
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-08-24
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2008-08-06
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-24
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-24
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2018-08-16
FCZ	Tube, Smoke Removal, Endoscopic	Gastroenterology, Urology	Class 1	876.1500	2021-11-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-24
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-08-24
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2023-08-24
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-24
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2013-02-13
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-23
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-23
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-08-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-24
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2023-08-24
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2024-01-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-24
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-24
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2012-01-26
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-24
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-24
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-24
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2023-08-24
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-08-24
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2026-03-09
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-23
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-23
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-23
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2007-03-26
GAN	Suture, Absorbable, Synthetic	General, Plastic Surgery	Class 2	878.4830	2008-03-20
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2026-06-02
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-24
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-23
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-09-13
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-09-13
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-24
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-24
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-08-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-24
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-08-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-24
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2007-05-03
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2008-03-26
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2008-03-26
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2008-03-26
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2008-03-26
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2008-03-26
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2008-03-26
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2008-03-26
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2023-08-23
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2024-06-12

Official Correspondent

Reynaldo Librojo

US Agent Details

Reynaldo Librojo Business: ETHICON Inc Email: rlibrojo@its.jnj.com Phone: (908) 8086028

Related Public Records

Same Entity

ETHICON INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3023251262	GATT Technologies BV	Nijmegen Gelderland, NL
3004903580	Johnson & Johnson do Brasil Ind. Com. de Prod. p/ Saude Ltda	SAO JOSE DOS CAMPOS Sao Paulo, BR
3013644499	JOHNSON & JOHNSON DO BRASIL INDUSTRIA E COMERCIO DE PRODUTOS PARA SAUDE LTDA	Guarulhos Sao Paulo, BR
3002294946	Johnson & Johnson MEDICAL GmbH	NORDERSTEDT Schleswig-Holstein, DE
3003702646	ETHICON SARL	NEUCHATEL, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0008-2023	Synthes (USA) Products LLC	2	Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0010-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006638824. Last updated year: 2026. Please use registration number 3006638824 when referencing this establishment in official correspondence.