Submission Details
| 510(k) Number | K091462 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 18, 2009 |
| Decision Date | December 15, 2009 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
Cleared
Traditional
SPECTRA MEDICAL SAFETY SCAPEL
Dec 2009
Decision
211d
Days
Class 1
Risk
About This 510(k) Submission
K091462 is an FDA 510(k) clearance for the SPECTRA MEDICAL SAFETY SCAPEL, a Handle, Scalpel (Class I — General Controls, product code GDZ), submitted by Spectra, Inc. (Wilmington, US). The FDA issued a Cleared decision on December 15, 2009, 211 days after receiving the submission on May 18, 2009. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
Device Classification
| Product Code | GDZ — Handle, Scalpel |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |
Manufacturer
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