510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K041435Substantially Equivalent

The Stripper Pgd

Mid-Atlantic Diagnostics, Inc., Marlton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K041435 is the FDA 510(k) clearance record for THE STRIPPER PGD, a class II device, cleared for Mid-Atlantic Diagnostics, Inc. on under FDA product code MQH (Microtools, Assisted Reproduction (Pipettes)). FDA records list 4 510(k) clearances for Mid-Atlantic Diagnostics, Inc., from to . As of , FDA records show no recalls naming K041435.

Clearance record

Decision date
Received
(124 days to decision)
Product code
MQH Microtools, Assisted Reproduction (Pipettes)
Regulation
21 CFR 884.6130
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Mid-Atlantic Diagnostics, Inc. 438 N. Elmwood Rd., Marlton NJ
510(k) summary
Statement
Third party review
No

Clearances, product code MQH

Trailing 12 months

FDA records hold no clearances under product code MQH in the trailing twelve months.

FDA records show no clearances under product code MQH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MQH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260