FDA applicant

Access Surgical Intl., Inc.

Plymouth, MA9 decisions1992–19950 recalls

FDA records 9 decisions for Access Surgical Intl., Inc. (Plymouth, MA) from 1992 to 1995: 9 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GEI (Electrosurgical, Cutting & Coagulation &…). No recall is 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 Access Surgical Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Access Surgical Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Access”

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

Access Scientific, Inc. 14 Access Vascular, Inc. 9 Access / God Loves You 4 Access Point Medical, LLC 4 Access Bio Incorporate 4 Access Bio, Inc. 3 Access Devices, Inc. 3 Access Pharmaceuticals, Inc. 2 Access Battery, Inc. 2 Access Radiology Corp. 2 Access Cardiosystems, Inc. 2 Access Point Technologies Ep, Inc. 1

Access Surgical Intl., Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Access”