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510(k) K942573

COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH by Richard Hamer Assoc., Inc. — Product Code FED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1994
Date Received
May 31, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

Other clearances by Richard Hamer Assoc., Inc.

  • K962439 — DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10) (September 3, 1996)
  • K951325 — COMFEEL PLUS PRESSURE RELIEF DRESSING (July 31, 1995)
  • K950934 — MPM HYDROGEL DRESSING (May 16, 1995)
  • K951327 — COMFEEL PLUS CONTOUR DRESSING (April 28, 1995)
  • K942283 — COMFEEL PLUS TRANSPARENT DRESSING (July 29, 1994)
  • K941263 — COMFEEL PLUS WOUND DRESSING (May 10, 1994)
  • K934839 — MESALT STERILE DRESSING (December 22, 1993)

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  • K250452 — CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0 (June 2, 2025)
  • K243710 — Disposable ureteral access sheath (April 11, 2025)
  • K250517 — Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator (March 21, 2025)
  • K243820 — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, I (January 31, 2025)