Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004060107

FEI Number

3004060107

Entity Name

PETERS SURGICAL

City/State/Country

BOULOGNE-BILLANCOURT Hauts-de-Seine, FR

Establishment Address

Immeuble Aurelium, 1 cours de l'ile Seguin, BOULOGNE-BILLANCOURT Hauts-de-Seine 92100, FR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

PETERS SURGICAL (Owner Number: 9009304)

Owner / Operator Contact Address

Immeuble Aurelium 1 cours de l'ile seguin, BOULOGNE BILLANCOURT, FR-92 92100, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K052701

PMA Number

N/A

All Registered Proprietary Names

Applier for VITALITEC Hemostatic Clips CARDIOXYL SLS-CLIP® VITALITEC TITANIUM HEMOSTATIC CLIP GEM MicroClips CLIP 9 VITALITEC® TITANIUM HEMOSTATIC CLIP ACIER SUTURES ADVANTIME SERTILAC VECTEC T'LIFT Laparoscopic retraction system SINUSORB PGA OPTIME COROLENE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HBT	Applier, Hemostatic Clip	General, Plastic Surgery	Class 1	878.4800	2016-06-08
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2007-06-13
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2016-06-08
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2005-09-21
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2024-07-22
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2005-02-15
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2018-06-19
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2007-03-15
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2006-09-20

Official Correspondent

Marie COMPAGNON-RIOBE

US Agent Details

Danielle LINDNER Business: VITALITEC INTERNATIONAL, INC. Email: Danielle.Lindner@admedsol.com Phone: (503) 8583083

Related Public Records

Same Entity

PETERS SURGICAL

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3001650400	PETERS SURGICAL	DOMALAIN Bretagne, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18
K123940	Demetech Corp.	DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE	2014-05-30
K050845	ETHICON, Inc.	MONOCRYL PLUS ANTIBACTERIAL SUTURE	2005-06-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-05	N/A	1	Hem-o-lok Endo5 Ligation Applier
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.
Z-0012-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - 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-0013-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - 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 3004060107. Last updated year: 2026. Please use registration number 3004060107 when referencing this establishment in official correspondence.