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510(k) K002838

GASTRIC SUCTION AND DRAINAGE CATHETER by Bioenterics Corp. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2001
Date Received
September 12, 2000
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 Bioenterics Corp.

  • K964561 — ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, (February 11, 1997)
  • K934084 — BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE (December 16, 1993)
  • K924753 — BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE (December 15, 1992)

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  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
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