510(k) Report

FDA applicant

Origin Medsystems, Inc.

Menlo Park, CA50 decisions1989–19997 recalls

FDA records 50 decisions for Origin Medsystems, Inc. (Menlo Park, CA) from 1989 to 1999: 50 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HET (Laparoscope, Gynecologic (And Accessories)). Its devices cite 3 predicates, 3 of them its own earlier devices. 7 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Origin Medsystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Origin Medsystems, Inc. since 2007.

Recalls per year

7in 2024

2024: 7
2007high 7 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Origin Medsystems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Origin Medsystems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery34decisions
  • HETLaparoscope, Gynecologic (And Accessories)4decisions
  • LZVSystem, Cement Removal Extraction2decisions
  • FHOPneumoperitoneum Needle2decisions
  • GEXPowered Laser Surgical Instrument1decision
  • HRXArthroscope1decision

Also: OCW (1), KTT (1), GEA (1), GEI (1), DXC (1), ODF (1).

Who builds on its devices?

Later devices cite its devices 28 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K981700Vasoview Dissection/Vessel Harvesting SystemOrigin Medsystems, Inc. · 19985cite it
  • K9606375MM EndoscopeOrigin Medsystems, Inc. · 19964cite it
  • K935426Preperitoneal Distention Balloon SystemOrigin Medsystems, Inc. · 19943cite it
  • K944415Origin Tacker SystemOrigin Medsystems, Inc. · 19943cite it
  • K920599Hook Surgical InstrumentOrigin Medsystems, Inc. · 19923cite it
  • K964171Vasoview Balloon Dissection SystemOrigin Medsystems, Inc. · 19972cite it

What has FDA decided for it lately?

  • K992353Blunt Tip Trocar PortOrigin Medsystems, Inc. · 1999
  • K981700Vasoview Dissection/Vessel Harvesting SystemOrigin Medsystems, Inc. · 1998
  • K972685Origin Ligator DeviceOrigin Medsystems, Inc. · 1997
  • K970611Origin Cardiac Stablizer OccluderOrigin Medsystems, Inc. · 1997
  • K965121CannulaOrigin Medsystems, Inc. · 1997
  • K964171Vasoview Balloon Dissection SystemOrigin Medsystems, Inc. · 1997
  • K962104Airlift Balloon Retracton SystemOrigin Medsystems, Inc. · 1996
  • K962005Extrahand Balloon RetractorOrigin Medsystems, Inc. · 1996

All 50 as Origin Medsystems, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K924011Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTFeb 28, 2024Class II
  • K924011Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSFeb 28, 2024Class II
  • K924011Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SBFeb 28, 2024Class II
  • K924011Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTFeb 28, 2024Class II
  • K924011Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNLFeb 28, 2024Class II
  • K924011Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNLFeb 28, 2024Class II

Other applicant names beginning “Origin”

FDA records each applicant name separately; these may or may not be the same firm.

Origin Medical Devices 1