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510(k) K031527

MODIFICATION TO CAVERMAP SURGICAL AID by Blue Torch Medical Technologies — Product Code FGM

K031527 is an FDA 510(k) premarket notification submitted by Blue Torch Medical Technologies for the device "MODIFICATION TO CAVERMAP SURGICAL AID". The FDA issued a decision of Substantially Equivalent on June 5, 2003. The device falls under product code FGM (Probe And Director, Gastro-Urology), a Class I device regulated under 21 CFR 876.4730. Blue Torch Medical Technologies has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2003
Date Received
May 15, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe And Director, Gastro-Urology
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances by Blue Torch Medical Technologies

  • K041732 — CAVERMAP SURGICAL AID (September 21, 2004)

Other clearances for product code FGM

  • K041732 — CAVERMAP SURGICAL AID (September 21, 2004)
  • K010098 — MODIFICATION TO CAVERMAP SURGICAL AID (February 1, 2001)
  • K993436 — CAVERMAP SURGICAL AID (February 11, 2000)
  • K944379 — ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG (February 15, 1995)
  • K944384 — ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG (February 15, 1995)
  • K944378 — ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG (February 15, 1995)

FDA data resources