Home / 510(k) Clearances / K021731

510(k) K021731

ADAPT OPEN ACCESS PORT, MODEL 41233 by Taut, Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2002
Date Received
May 24, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, General & Plastic Surgery
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Taut, Inc.

  • K023261 — ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244 (December 13, 2002)
  • K011018 — TAUT BALLOON CATHETER, MODEL 50640 (June 22, 2001)
  • K003703 — TAUT-INSUFFLATION NEEDLE (February 22, 2001)
  • K010007 — ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP (February 22, 2001)
  • K992907 — INTRADUCER (October 5, 1999)
  • K992904 — MINI-PORT (October 5, 1999)
  • K972112 — INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 (December 1, 1997)
  • K962003 — TUAT SPLATTER CONTROL SHIELD SCS-300 (July 18, 1996)
  • K960883 — INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8 (March 20, 1996)
  • K945486 — SPLATTER CONTROL SHIELD (February 28, 1995)

Other clearances for product code GCJ

  • K252714 — C-Lant Port (February 27, 2026)
  • K253978 — Universal Seal (5-12 mm) (February 24, 2026)
  • K260185 — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with (February 18, 2026)
  • K260177 — Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) (February 12, 2026)
  • K251923 — Medical Shaver System (Morcellator) (YSB-IIIA) (January 29, 2026)
  • K252957 — Pneumo Dissector Hook (January 23, 2026)
  • K254014 — Connected OR Hub with Device and Voice Control; SDC4K Information Management Sys (January 13, 2026)
  • K250927 — KARL STORZ Cholangiography Set (November 22, 2025)
  • K242606 — Nuvis® Wireless HD Camera System (Nuvis-2K) (November 20, 2025)
  • K252442 — Kii Structural Balloon Access System (October 31, 2025)