Home / 510(k) Clearances / K831631

510(k) K831631

GASTROSTOMY FEEDING SET by Plasco, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
May 20, 1983
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 Plasco, Inc.

  • K980066 — CPR FILTERSHIELD (July 16, 1998)
  • K953414 — CPR MICROMASK WITH OXYGEN INLET (March 20, 1996)
  • K951483 — CPR MICROMASK (October 19, 1995)
  • K950769 — CPR MICROMASK PLUS CATALOG NO 73-402 (March 10, 1995)
  • K950770 — CPR MICROSHIELD II (March 10, 1995)
  • K943386 — CPR MICROMASK (February 21, 1995)
  • K932649 — PHARMAFEED (November 16, 1993)
  • K880337 — MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 (April 14, 1988)
  • K870623 — ENTERAL ADMINISTRATION SET (June 26, 1987)
  • K870796 — MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY (April 1, 1987)

Other clearances for product code KNT

  • K250389 — XNY Disposable Gastric Calibration Tube (April 10, 2025)
  • 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)