510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120898Substantially Equivalent

Keyport System, Includes: Keyport Silicone Sealing Insert 8850Xxx Keyport Trucar 8850Xx Keyport Trocar 8850Xx Sealing Ca

Richard Wolf Medical Instruments Corp., Vernon Hills IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120898 is the FDA 510(k) clearance record for KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA, a class II device, cleared for Richard Wolf Medical Instruments Corp. on under FDA product code OTJ (Laparoscopic Single Port Access Device). FDA's definition for product code OTJ reads: "A multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery". FDA records list 153 510(k) clearances for Richard Wolf Medical Instruments Corp., from to . As of , FDA records show no recalls naming K120898.

Clearance record

Decision date
Received
(130 days to decision)
Product code
OTJ Laparoscopic Single Port Access Device
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Richard Wolf Medical Instruments Corp. 353 Corporate Woods Pkwy., Vernon Hills IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OTJ

Trailing 12 months

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

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