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510(k) K950836

REDFIELD INFRARED COAGULATOR by Hogan & Hartson — Product Code KNS

K950836 is an FDA 510(k) premarket notification submitted by Hogan & Hartson for the device "REDFIELD INFRARED COAGULATOR". The FDA issued a decision of Substantially Equivalent on March 24, 1995. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Hogan & Hartson has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1995
Date Received
February 24, 1995
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 Hogan & Hartson

  • K974168 — COOPERSURGICAL INFRARED COAGULATOR (January 23, 1998)
  • K973849 — BIOABSORBABLE BANKART TACK (January 6, 1998)
  • K973162 — DUAL RADIATION TARGETING SYSTEM DRTS DRAPE (November 20, 1997)
  • K950169 — RIBOSOMAL P EIA TEST SYSTEM (May 23, 1996)
  • K942389 — TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES (February 16, 1996)
  • K946217 — CARDIOLIPIN M EIA TEST SYSTEM (January 24, 1996)
  • K946216 — CARDIOLIPIN A EIA TEST SYSTEM (January 24, 1996)
  • K946215 — CARDIOLIPIN G EIA TEST SYSTEM (January 24, 1996)
  • K946186 — CHAL-2500 (August 14, 1995)
  • K941566 — COMPUSPEAK (June 30, 1995)

Other clearances for product code KNS

  • 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)
  • K241855 — SB Knife Jr2 (MD-47702 and MD-47702L) (March 26, 2025)

FDA data resources