510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880318Substantially Equivalent

Rovenstein Forceps

Eastmed Enterprises, Inc., Marlton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880318 is the FDA 510(k) clearance record for ROVENSTEIN FORCEPS, a class I device, cleared for Eastmed Enterprises, Inc. on under FDA product code BWB (Forceps, Tube Introduction). FDA records list 13 510(k) clearances for Eastmed Enterprises, Inc., from to . As of , FDA records show no recalls naming K880318.

Clearance record

Decision date
Received
(55 days to decision)
Product code
BWB Forceps, Tube Introduction
Regulation
21 CFR 868.5780
Device class
Class I
Review panel
Anesthesiology
Applicant
Eastmed Enterprises, Inc. 5 Pembury Ct., Marlton NJ
Third party review
No

Clearances, product code BWB

Trailing 12 months

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

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