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
K083378Substantially Equivalent

Synergy

Innerspace, Inc., Tustin CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083378 is the FDA 510(k) clearance record for SYNERGY, a class II device, cleared for Innerspace, Inc. on under FDA product code GWM (Device, Monitoring, Intracranial Pressure). FDA records list 8 510(k) clearances for Innerspace, Inc., from to . As of , FDA records show no recalls naming K083378.

Clearance record

Decision date
Received
(319 days to decision)
Product code
GWM Device, Monitoring, Intracranial Pressure
Regulation
21 CFR 882.1620
Device class
Class II
Review panel
Neurology
Applicant
Innerspace, Inc. 1622 Edinger Ave. Suite C, Tustin CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GWM

Trailing 12 months
1 clearance under product code GWM 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 GWM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260