Home / 510(k) Clearances / K931822

510(k) K931822

CARAPACE PELVIC EXAM TRAYS by Carapace, Inc. — Product Code MLT

K931822 is an FDA 510(k) premarket notification submitted by Carapace, Inc. for the device "CARAPACE PELVIC EXAM TRAYS". The FDA issued a decision of Substantially Equivalent (kit) on March 7, 1994. The device falls under product code MLT (Pelvic Exam Kit), a Class II device regulated under 21 CFR 884.4530. Carapace, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 7, 1994
Date Received
April 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pelvic Exam Kit
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

Other clearances by Carapace, Inc.

  • K931722 — CARAPACE LABOR AND DELIVERY SETS (March 23, 1994)
  • K931729 — I.V. START KIT (February 22, 1994)
  • K931669 — CARAPACE DEBRIDEMENT KITS (February 7, 1994)
  • K931820 — CARAPACE STILLWATER BOWL SET (February 7, 1994)
  • K931760 — CARAPACE PACKING GAUZE TRAYS (February 4, 1994)
  • K932653 — SWISSTEK 2000(TM) CAST REMOVAL SYSTEM (January 28, 1994)
  • K931819 — CARAPACE SUTURE REMOVAL TRAYS (January 26, 1994)
  • K931758 — CARAPACE WOUND DRESSING KITS & LACERATION TRAYS (January 26, 1994)
  • K931759 — CARAPACE STERILE GAUZE TRAYS (January 25, 1994)
  • K931670 — CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS (January 25, 1994)

FDA data resources