510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053638Substantially Equivalent

Mani Needle & Suture Pack (Silk)

Mani, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053638 is the FDA 510(k) clearance record for MANI NEEDLE & SUTURE PACK (SILK), a class II device, cleared for Mani, Inc. on under FDA product code GAP (Suture, Nonabsorbable, Silk). FDA records list 4 510(k) clearances for Mani, Inc., from to . As of , FDA records show no recalls naming K053638.

Clearance record

Decision date
Received
(141 days to decision)
Product code
GAP Suture, Nonabsorbable, Silk
Regulation
21 CFR 878.5030
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Mani, Inc. 1301k St., NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAP

Trailing 12 months

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

FDA records show no clearances under product code GAP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GAP, 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