510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161092Substantially Equivalent

GalaSHAPE 3D

Tepha, Inc., Lexington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161092 is the FDA 510(k) clearance record for GalaSHAPE 3D, a class II device, cleared for Tepha, Inc. on under FDA product code OOD (Surgical Film). FDA's definition for product code OOD reads: "To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal...". FDA records list 16 510(k) clearances for Tepha, Inc., from to . As of , FDA records show one recall naming K161092.

Clearance record

Decision date
Received
(127 days to decision)
Product code
OOD Surgical Film
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Tepha, Inc. 99 Hayden Ave., Lexington MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OOD

Trailing 12 months

FDA records hold no clearances under product code OOD in the trailing twelve months.

FDA records show no clearances under product code OOD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OOD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260