510(k) Report

FDA applicant

Endo Technic Corp.

Natick, MA10 decisions1986–19992 recalls

FDA records 10 decisions for Endo Technic Corp. (Natick, MA) from 1986 to 1999: 10 510(k) clearances. Most are in product codes HET (Laparoscope, Gynecologic (And Accessories)) and GEX (Powered Laser Surgical Instrument). Its devices cite 4 predicates, 0 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Endo Technic Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Endo Technic Corp. since 2007.

Recalls per year

2in 2013

2013: 2
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Endo”

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