510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963134Substantially Equivalent

Drain/slit Sponge (Non-Sterile and Sterile)

Igenics, Inc., Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963134 is the FDA 510(k) clearance record for DRAIN/SLIT SPONGE (NON-STERILE AND STERILE), cleared for Igenics, Inc. on under FDA product code EFQ (Gauze/Sponge, Internal). FDA records list 3 510(k) clearances for Igenics, Inc., from to . As of , FDA records show no recalls naming K963134.

Clearance record

Decision date
Received
(25 days to decision)
Product code
EFQ Gauze/Sponge, Internal
Device class
Unclassified
Review panel
Unknown
Applicant
Igenics, Inc. One Beacon St., Boston MA
510(k) summary
Summary
Third party review
No

Clearances, product code EFQ

Trailing 12 months

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

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