510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K101794Substantially Equivalent

Asc Triport Laparoscopic Access Device Model Tprt-02-01 (Wa58000t), Asc Quadport Laparoscopic Asscess Device Qprt-01 (Wa

Advanced Surgical Concepts, North Attleboro MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101794 is the FDA 510(k) clearance record for ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA, a class II device, cleared for Advanced Surgical Concepts 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 12 510(k) clearances for Advanced Surgical Concepts, from to . As of , FDA records show no recalls naming K101794.

Clearance record

Decision date
Received
(154 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
Advanced Surgical Concepts 49 Plain St., North Attleboro MA
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