Name: Predicase
Price: 199 USD

K-number	K061539
Device name	GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE
Applicant	Clinical Innovations, LLC
Product code	HFX
Device class	Class II
Decision date	Sep 20, 2007
Decision	Substantially Equivalent
Regulation	884.4530

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE

Everything you need for a 510(k) submission. Nothing you don't.