510(k) Report

FDA applicant

Fiber Delivery Concepts, Inc.

Somerville, MA4 decisions1990–19910 recalls

FDA records 4 decisions for Fiber Delivery Concepts, Inc. (Somerville, MA) from 1990 to 1991: 4 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). 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, general and plastic surgery panel, where it files most

How often FDA has decided Fiber Delivery Concepts, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fiber Delivery Concepts, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Fiber Delivery Concepts, 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

Other applicant names beginning “Fiber”

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