CAVERMAP SURGICAL AID— 510(k) K993436

Substantially Equivalent

Uromed Corp.

FDA 510(k) clearance K993436 for CAVERMAP SURGICAL AID, Substantially Equivalent on 2000-02-11. Applicant: Uromed Corp.. Device class: 1.

Clearance details

Applicant: Uromed Corp.
Product code: Code FGM
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1999-10-12
Decision date: 2000-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwood, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FGM

K041732 — CAVERMAP SURGICAL AID2004-09-21
K031527 — MODIFICATION TO CAVERMAP SURGICAL AID2003-06-05
K010098 — MODIFICATION TO CAVERMAP SURGICAL AID2001-02-01
K944378 — ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG1995-02-15
K944379 — ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG1995-02-15

More clearances from Uromed Corp.

K010213 — MODIFICATION TO CAVERMAP SURGICAL AID2001-04-20
K000507 — CAVERMAP SURGICAL AID2000-04-21
K982226 — UROMED BRACHYTHERAPHY IODINE-125 SOURCES1999-05-13
K980717 — UROMED SLING KIT1998-05-22
K974600 — UROMED PATCH1998-03-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.