Pelvic Exam Kit

FDA product code MLT · Class II (moderate risk) · 21 CFR 884.4530 · Obstetrics/Gynecology

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.

1510(k) clearances
0PMA approvals
10recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K931822Carapace Pelvic Exam TraysMLT · Traditional Carapace, Inc.03/07/1994SESK

Recalls

RecallProductFirmInitiated
Z-2502-2026 Class IIMEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU…During an internal review, Medline identified representative samples did not meet applicable performance… Medline Industries, LP05/04/2026Open, Classified
Z-2430-2026 Class IIMedline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619MKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack… Medline Industries, LP04/27/2026Open, Classified
Z-1612-2025 Class IIMedline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… MEDLINE INDUSTRIES, LP - Northfield03/03/2025Open, Classified
Z-0642-2025 Class IIMEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2)…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… MEDLINE INDUSTRIES, LP - Northfield10/09/2024Open, Classified
Z-3045-2024 Class IIMedline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield04/08/2024Open, Classified
Z-2089-2023 Class IICustom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. DeRoyal Industries Inc05/30/2023Open, Classified
Z-1090-2023 Class IISterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPYSterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… MEDLINE INDUSTRIES, LP - Northfield11/17/2022Open, Classified
Z-1072-2020 Class IICenturion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHTIncomplete seals on the sterile package may compromise the sterility Centurion Medical Products Corporation12/11/2019Terminated
Z-1055-2020 Class IICenturion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC…Incomplete seals on the sterile package may compromise the sterility Centurion Medical Products Corporation12/11/2019Terminated
Z-1050-2020 Class IICenturion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090 DYNDE1037…Incomplete seals on the sterile package may compromise the sterility Centurion Medical Products Corporation12/11/2019Terminated