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510(k) K895842

BITOME(TM) BIPOLAR SPHINCTEROTOME by Everest Medical Corp. — Product Code KNS

K895842 is an FDA 510(k) premarket notification submitted by Everest Medical Corp. for the device "BITOME(TM) BIPOLAR SPHINCTEROTOME". The FDA issued a decision of Substantially Equivalent on January 11, 1990. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Everest Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1990
Date Received
October 2, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Everest Medical Corp.

  • K003060 — PLASMAKINETIC GENERATOR (October 31, 2000)
  • K000496 — EVERSHEARS BIPOLAR SCISSORS (April 24, 2000)
  • K993412 — BITX PROBES (March 31, 2000)
  • K994336 — BITX PROBES (February 8, 2000)
  • K971565 — BICOAG COAGULATING FORCEPS (March 12, 1998)
  • K955001 — EVERSHEARS SCISSORS, BILAP PROBES, BICOAG FORCEPS (December 13, 1995)
  • K945975 — EVERSHEARS(R) SCISSORS, BILAP(R) PROBES, BICOAG(R) FORCEPS (December 21, 1994)
  • K922509 — LAPAROSCOPIC ELECTROSURG DEVICE W/IRRIGA & ASPIRA (October 1, 1992)
  • K922246 — TUBING SET W/ IRRIGATION & ASPIRATION VALVING (September 2, 1992)
  • K920089 — MONOPOLAR COAGULATING POLYPECTOMY SNARE (March 31, 1992)

Other clearances for product code KNS

  • K262460 — Rezum System (September 3, 2026)
  • K260962 — Sphincterotome (May 21, 2026)
  • K252388 — Vanquish Water Vapor Ablation Device (November 26, 2025)
  • K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) (November 25, 2025)
  • K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Si (October 17, 2025)
  • K250351 — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical (October 10, 2025)
  • K251104 — SureTome™ SW Sphincterotome with DomeTip (September 29, 2025)
  • K251226 — Aqua Medical RF Vapor Ablation System (August 8, 2025)
  • K250584 — Rezum System (June 11, 2025)
  • K242774 — SpydrBlade Flex Instrument (PRD-RG1-001) (June 6, 2025)

FDA data resources