Atlas FDA

CAVERMAP SURGICAL AID

FDA 510(k) clearance K993436 · decided 2000-02-11

Clearance details

K-number
K993436
Device name
CAVERMAP SURGICAL AID
Applicant
Uromed Corp.
Decision
Substantially Equivalent
Date received
1999-10-12
Decision date
2000-02-11
Days to decision
122 days
Clearance type
Traditional
Product code
FGM
Device class
1
Regulation number
876.4730
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Norwood, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
CAVERMAP SURGICAL AID (K041732)Blue Torch Medical Technologies2004-09-21
MODIFICATION TO CAVERMAP SURGICAL AID (K031527)Blue Torch Medical Technologies2003-06-05
MODIFICATION TO CAVERMAP SURGICAL AID (K010098)Uromed Corp.2001-02-01
ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG (K944379)Regulatory & Marketing Services, Inc.1995-02-15
ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG (K944378)Regulatory & Marketing Services, Inc.1995-02-15
ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG (K944384)Regulatory & Marketing Services, Inc.1995-02-15

Recalls involving this device

RecordFirmDate
CaverMap Surgical Aid Disposable Kit with Focused Probe Tip, Sterile Part Number: 8305 recall (Z-1235-03)Blue Torch Medical Technologies2003-09-13

PMA approvals by this applicant

RecordFirmDate
RELIANCE URINARY CONTROL INSERT & SIZING DEVICE (P960020/S001)Uromed Corp.1999-04-01
RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE (P960020)Uromed Corp.1996-08-16