Back to free search
Home / Search / K862861

SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE

Directed Energy, Inc. · Class II · Cleared Oct 27, 1986

K-numberK862861
Device nameSURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE
ApplicantDirected Energy, Inc.
Product codeHHR
Device classClass II
Decision dateOct 27, 1986
DecisionSubstantially Equivalent
Regulation884.4550
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 →

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

14-day free trial. No setup. Cancel anytime.

Start free trial →
Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →