510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K062510Substantially Equivalent

Aesculap Sterilcontainer System

Aesculap Inc, Center Valley PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062510 is the FDA 510(k) clearance record for AESCULAP STERILCONTAINER SYSTEM, a class II device, cleared for Aesculap on under FDA product code FRG (Wrap, Sterilization). FDA records list 269 510(k) clearances for Aesculap, from to . As of , FDA records show no recalls naming K062510.

Clearance record

Decision date
Received
(81 days to decision)
Product code
FRG Wrap, Sterilization
Regulation
21 CFR 880.6850
Device class
Class II
Review panel
General Hospital
Applicant
Aesculap 3773 Corporate Pkwy., Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRG

Trailing 12 months
5 clearances under product code FRG in the twelve months to November 2026, May 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FRG, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20260
May 20262
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260