Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006981798

FEI Number

3006981798

Entity Name

RIVERPOINT MEDICAL LLC

City/State/Country

Portland, OR, US

Establishment Address

825 NE 25th Ave, Portland, OR 97232, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Riverpoint Medical LLC (Owner Number: 10024181)

Owner / Operator Contact Address

825 NE 25th Avenue, Portland, OR 97232, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K001185

PMA Number

N/A

All Registered Proprietary Names

CP COTTON UMBILICAL TAPE OrthoButton AL SILK C-PTFE Surgical Suture Riversilk Parcus Braid RiverLon FixFiber RiverPro HS Fiber Riverbond RP Cutting Needle HS SutureTape OrthoButton CL FixLoop SURGICAL STEEL RootMend MRR CP-FIBER; ORTHOFIBER; POWERFIBER FixLoop+ OrthoButton AL Vilet II Quick Mono Q PDM Vilet II Applicator Needle Brachytherapy Needles Applicator Needles RP Brachytherapy Needle RP Sleeve RP Spacer Gold Marker Orthopedic Surgical Needles (RiverPass) RP Brachytherapy Grid HS Fiber POLYBOND Canalicular plugs Orthopedic Drill Bits (RiverDrill) POLYPRO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXM	Truss, Umbilical	Gastroenterology, Urology	Class 1	876.5970	2024-08-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-03-14
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2024-08-15
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	Class 2	878.5035	2024-08-15
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2013-01-25
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-10-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-10-12
GAS	Suture, Nonabsorbable, Synthetic, Polyester	General, Plastic Surgery	Class 2	878.5000	2010-09-23
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2010-09-23
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2010-09-23
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2010-09-23
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2010-09-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-08-30
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2010-01-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2015-08-17
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2016-02-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2026-03-16
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2024-08-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-08-21
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2026-03-16
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2016-06-10
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2024-08-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-11-25
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-04-28
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2025-04-28
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2024-08-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2017-07-20
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2025-11-15
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2010-09-23
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2010-09-23
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2015-12-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-02-28
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2016-03-01
OJH	Orthopedic Tray	General, Plastic Surgery	Class 1	878.4800	2026-05-01
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	Class 2	878.5035	2014-09-26
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-11-05
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-11-05
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2011-06-24
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2011-06-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-12-04
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-08-04
HWQ	Passer	Orthopedic	Class 1	888.4540	2022-06-29
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2014-04-14
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2020-12-23
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2019-06-11
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2024-08-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-11-21
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-07-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-08-07
LZU	Plug, Punctum	Unknown	Class U	N/A	2018-08-21
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2022-06-29
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-03-08
OVN	Suture Kit	General, Plastic Surgery	Class 2	878.4830	2026-05-12
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2024-08-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Riverpoint Medical LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3027454646	Riverpoint Medical CR S.R.L.	Coyol Alajuela, CR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0014-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - 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-0015-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" V-20 Taper, Product Number: CV417G, UDI: 20884521149370 - 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-0016-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting, Product Number: SV6830, UDI: 20884521152349 - 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-0017-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-24, Product Number: SV9911G, UDI: 20884521149776 - 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-0018-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper, Product Number: CV3110, UDI: 20884521150918 - 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-0019-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-11, Product Number: SVP2294, UDI: 20884521177403 - 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-0020-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-12, Cutting Product Number: CV486, UDI: 20884521150925 - 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-0021-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" SC-1, Product Number: SV2239, UDI: 20884521151779 - 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-0022-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 VL 18" P-10, Product Number: SV32, UDI: 20884521153117 - 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-0023-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 30" P-10 Cutting, Product Number: SV4893, UDI: 20884521151717 - 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-0024-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" CV-25 Taper, Product Number: CV3100, UDI: 20884521150901 - 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-0025-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cutting, Product Number: SV496G, UDI: 20884521149691 - 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-0026-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" V-20 Taper, Product Number: CV416G, UDI: 20884521149363 - 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-0027-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-21 Taper, Product Number: CV947, UDI: 20884521153056 - 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-0028-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" CV-23 Taper, Product Number: CV1213, UDI: 20884521150758 - 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-0029-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cut, Product Number: SV496, UDI: 20884521184258 - 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-0030-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-14, Product Number: SVP2251, UDI: 20884521177380 - 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-0031-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" KV-11, TaperCutting, Product Number: CV2293, UDI: 20884521151588 - 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-0032-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" PC-10, Product Number: SV835G, UDI: 20884521149721 - 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-0033-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 36" KV-34, TaperCutting Product Number: CV916, UDI: 20884521153032 - 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-0034-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product Number: CV605, UDI: 20884521152295 - 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-0035-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-12 Cutting, Product Number: SV2295, UDI: 20884521151397 - 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-0036-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-21 Taper CV946, UDI: 20884521151298 - 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-0037-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11 Cutting CV4731, UDI: 20884521151359 - 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-0038-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-11 SVP2295, UDI: 20884521177410 - 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-0039-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-25 CV604, UDI: 20884521152288 - 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-0040-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting 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-0041-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" PC-11 SV487G, UDI: 10884521149595 - 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-0042-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25 CV605, UDI: 20884521152295 - 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-0043-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" KV-15 TaperCutting CV2279, UDI: 20884521151632 - 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-0044-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-12 Cutting SV497G, UDI: 20884521149707 - 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 3006981798. Last updated year: 2026. Please use registration number 3006981798 when referencing this establishment in official correspondence.