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510(k) K212728

Standard Bougie, 38 Fr. and Hand Pump by Standard Bariatrics — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2021
Date Received
August 27, 2021
Clearance Type
Special
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 Standard Bariatrics

  • K231603 — Standard Staple-Line Reinforcement (SSLR23) (October 6, 2023)
  • K222085 — Standard Tapered Bougie, 38 Fr. (October 31, 2022)
  • K210437 — Standard Bougie, 38 Fr. (June 29, 2021)
  • K210278 — Titan SGS (April 28, 2021)
  • K200517 — Standard Trocar (April 9, 2020)
  • K191885 — Standard Bougie (April 8, 2020)
  • K190788 — Disposable Standard Clamp (April 18, 2019)
  • K181608 — Disposable Standard Clamp (September 27, 2018)
  • K170379 — Disposable Standard Clamp (July 19, 2017)
  • K161720 — Standard Clamp (October 24, 2016)

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)