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
K180542Substantially Equivalent

NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe

Boston Endo Surgical Tech, Bridgeport CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180542 is the FDA 510(k) clearance record for NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe, a class II device, cleared for Boston Endo Surgical Tech, on under FDA product code PDQ (Neurosurgical Nerve Locator). FDA's definition for product code PDQ reads: "To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery". FDA records list 2 510(k) clearances for Boston Endo Surgical Tech,, from to . As of , FDA records show no recalls naming K180542.

Clearance record

Decision date
Received
(174 days to decision)
Product code
PDQ Neurosurgical Nerve Locator
Regulation
21 CFR 874.1820
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Boston Endo Surgical Tech, Division Of Lacey Manufacturing Co., Llc, Bridgeport CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PDQ

Trailing 12 months
2 clearances under product code PDQ in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PDQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260