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510(k) K822565

NEEDLE CATHETER JEJUNOSTOMY KIT by Bio-Research Associates, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1982
Date Received
August 22, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Bio-Research Associates, Inc.

  • K130158 — M-SCAN (July 25, 2013)
  • K082927 — BIOEMG III (February 6, 2009)
  • K061799 — QUADRATENS, MODEL QT-42 (August 28, 2006)
  • K003176 — BIOEMG II AND BIOJVA (January 4, 2001)
  • K991756 — 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE (December 10, 1999)
  • K981563 — BIOPAK MEASUREMENT SYSTEM (September 15, 1998)
  • K952218 — JT-3 ELECTROGNATHOGRAPH (September 21, 1995)
  • K873947 — BIO-EMG MODEL 800 (April 27, 1988)
  • K844618 — BIO-TENS (August 21, 1985)

Other clearances for product code KNT

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  • K243228 — Flexi-Seal AIR (with ENFit Connector) (March 28, 2025)
  • K242336 — hygh-tec Drainage II (January 17, 2025)
  • K242901 — ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN (January 10, 2025)
  • K241169 — Entarik NI Feeding Tube System (November 22, 2024)
  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
  • K240965 — CORTRAK* 2 Enteral Access System (20-0950) (June 6, 2024)
  • K233591 — Stylus (May 31, 2024)
  • K241039 — ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B (May 16, 2024)
  • K234033 — ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (May 6, 2024)