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510(k) K964561

ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA by Bioenterics Corp. — Product Code FDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1997
Date Received
November 13, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Fiberoptic
Device Class
Class I
Regulation Number
876.4530
Review Panel
GU
Submission Type

Other clearances by Bioenterics Corp.

  • K002838 — GASTRIC SUCTION AND DRAINAGE CATHETER (July 9, 2001)
  • K934084 — BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE (December 16, 1993)
  • K924753 — BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE (December 15, 1992)

Other clearances for product code FDG

  • K945421 — CHAKOFF ENDOSCOPY (December 23, 1994)