510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K091692Substantially Equivalent

Aesculap Peek Craniofix

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

K091692 is the FDA 510(k) clearance record for AESCULAP PEEK CRANIOFIX, a class II device, cleared for Aesculap, Inc. on under FDA product code GXR (Cover, Burr Hole). FDA records list 269 510(k) clearances for Aesculap, Inc., from to . As of , FDA records show no recalls naming K091692.

Clearance record

Decision date
Received
(428 days to decision)
Product code
GXR Cover, Burr Hole
Regulation
21 CFR 882.5250
Device class
Class II
Review panel
Neurology
Applicant
Aesculap, Inc. 3773 Corporate Pkwy., Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXR

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