Atlas FDA

EGN

7 FDA 510(k) clearances · Product code

25 daysmedian time to decision
68 days90th percentile
7clearances measured

FDA profile

Official device name
Scissors, Surgical Tissue, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Medical specialty
Dental
Adverse events (MAUDE)
1994: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
GXP DENTAL X-RAY PROCESSOR (K932675)Gendex Corp.1993-07-26
1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS (K851720)Artiberia1985-07-02
TONSIL SCISSORS 7 (K821292)Conphar, Inc.1982-05-28
MAYO SCISSOR CURYED 5 1/2 (K821276)Conphar, Inc.1982-05-28
TONSIL SCISSORS STRAIGHT 5 1/2 (K821294)Conphar, Inc.1982-05-28
MAYO SCISSOR STRAIGHT 5 1/2 (K821275)Conphar, Inc.1982-05-28
CONPHAR (K821077)Conphar, Inc.1982-05-24

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Every clearance here is in the API, with alerts when new ones post.