510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K090271Substantially Equivalent

Hydrocoat Mesh

Promethean Surgical Devices, Inc., East Harford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090271 is the FDA 510(k) clearance record for HYDROCOAT MESH, a class II device, cleared for Promethean Surgical Devices, Inc. on under FDA product code FTL (Mesh, Surgical, Polymeric). FDA records list one 510(k) clearance for Promethean Surgical Devices, Inc. As of , FDA records show no recalls naming K090271.

Clearance record

Decision date
Received
(344 days to decision)
Product code
FTL Mesh, Surgical, Polymeric
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Promethean Surgical Devices, Inc. 111 Roberts St., East Harford CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FTL

Trailing 12 months
2 clearances under product code FTL in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FTL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260