510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893415Substantially Equivalent

Trans-Oral Depth Gauge

Ruggles Corp., No. Quincy MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893415 is the FDA 510(k) clearance record for TRANS-ORAL DEPTH GAUGE, a class I device, cleared for Ruggles Corp. on under FDA product code LYQ (Accessories, Fixation, Spinal Intervertebral Body). FDA records list 5 510(k) clearances for Ruggles Corp., from to . As of , FDA records show no recalls naming K893415.

Clearance record

Decision date
Received
(36 days to decision)
Product code
LYQ Accessories, Fixation, Spinal Intervertebral Body
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Ruggles Corp. 38 Billings Rd., No. Quincy MA
Third party review
No

Clearances, product code LYQ

Trailing 12 months

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

FDA records show no clearances under product code LYQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LYQ, 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