Submission Details
| 510(k) Number | K962683 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 10, 1996 |
| Decision Date | January 10, 1997 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR
Jan 1997
Decision
184d
Days
Class 2
Risk
About This 510(k) Submission
K962683 is an FDA 510(k) clearance for the SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR, a Insufflator, Laparoscopic (Class II — Special Controls, product code HIF), submitted by Deknatel, Inc. (North Attleboro, US). The FDA issued a Cleared decision on January 10, 1997, 184 days after receiving the submission on July 10, 1996. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1730.
Device Classification
| Product Code | HIF — Insufflator, Laparoscopic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1730 |
Manufacturer
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