510(k) Report

FDA applicant

Generic Medical Device, Inc.

Houston, TX4 decisions2007–20112 recalls

FDA records 4 decisions for Generic Medical Device, Inc. (Houston, TX) from 2007 to 2011: 4 510(k) clearances. Most are in product codes OTN (Mesh, Surgical, Synthetic, Urogynecologic, For…) and FTL (Mesh, Surgical, Polymeric). Its devices cite 7 predicates, 1 of them its own earlier devices. 2 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, general and plastic surgery panel, where it files most

How often FDA has decided Generic Medical Device, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 22009: 12011: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2011

2009: 12011: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Generic Medical Device, 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?

  • OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic…2decisions
  • FTLMesh, Surgical, Polymeric1decision
  • HFXClamp, Circumcision1decision

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 20093cite it

What has FDA decided for it lately?

  • K111219GMD Universal Urinary Incontinence SlingGeneric Medical Device, Inc. · 2011
  • K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 20092 recalls
  • K070018Universal Surgical Mesh, Model 100Generic Medical Device, Inc. · 2007
  • K063429GMD Universal Circumcision Clamp, Model 200Generic Medical Device, Inc. · 2007

All 4 as Generic Medical Device, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K083471The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is…Feb 14, 2011
  • K083471GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18. Intended for use…Jun 18, 2009

Other applicant names beginning “Generic”

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

Generic Medical, Inc. 1Generic Medical Devices, Inc. 1Generic Laboratory, Ltd. 1