510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K142315Substantially Equivalent

MINOP Disposable Introducer 26F

Aesculap Inc, Center Valley PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K142315 is the FDA 510(k) clearance record for MINOP Disposable Introducer 26F, a class II device, cleared for Aesculap, Inc. on under FDA product code GWG (Endoscope, Neurological). FDA's definition for product code GWG reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 269 510(k) clearances for Aesculap, Inc., from to . As of , FDA records show no recalls naming K142315.

Clearance record

Decision date
Received
(87 days to decision)
Product code
GWG Endoscope, Neurological
Regulation
21 CFR 882.1480
Device class
Class II
Review panel
Neurology
Applicant
Aesculap, Inc. 3773 Corporate Pkwy., Center Valley PA
510(k) summary
Statement
Third party review
No

Clearances, product code GWG

Trailing 12 months
4 clearances under product code GWG in the twelve months to October 2026, October 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GWG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20262