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510(k) K941161

FLEXIBLE GRASPING FORCEPS by Surgical Technologies, Inc. — Product Code EOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1994
Date Received
March 11, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bronchoscope (Flexible Or Rigid)
Device Class
Class II
Regulation Number
874.4680
Review Panel
EN
Submission Type

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. 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 https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Surgical Technologies, Inc.

  • K941992 — CYSTOSCOPE (November 30, 1995)
  • K942029 — ARTHROSCOPE (November 8, 1995)
  • K946136 — INFINITECH LIGHTED INFUSION CANNULA (October 2, 1995)
  • K952566 — OSCILFLATOR (August 31, 1995)
  • K951918 — SURGICAL TECHNOLOGIES, INC. SYRINGE (July 20, 1995)
  • K950683 — ARTHROGRAM TRAY (May 6, 1995)
  • K946135 — INFINITECH ASPIRATING LASER PROBE (April 18, 1995)
  • K946181 — INFINITECH SOFT TIP FLUTE NEEDLE (March 14, 1995)
  • K942030 — BIOPSY SCISSORS (June 27, 1994)
  • K942482 — PRESSURE MONITORING EXTENSION (June 14, 1994)

Other clearances for product code EOQ

  • K250863 — FUJIFILM Ultrasonic Endoscope EB-710US (December 12, 2025)
  • K251731 — KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) (December 5, 2025)
  • K252045 — Ion Endoluminal System (IF1000) (September 23, 2025)
  • K251894 — Himaging Bronchscope System (September 23, 2025)
  • K252528 — Ion Endoluminal System (IF1000) (September 5, 2025)
  • K251752 — Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) (August 27, 2025)
  • K251823 — UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchosco (August 11, 2025)
  • K250232 — Vathin® Video Bronchoscope System (July 25, 2025)
  • K250862 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEO (June 23, 2025)
  • K244017 — FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 (June 13, 2025)