Submission Details
| 510(k) Number | K013460 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 18, 2001 |
| Decision Date | January 17, 2002 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
Cleared
Traditional
K013460 - SWIFT LOW PROFILE CUP (PRO CUP)
(FDA 510(k) Clearance)
Jan 2002
Decision
91d
Days
Class 2
Risk
K013460 is an FDA 510(k) clearance for the SWIFT LOW PROFILE CUP (PRO CUP), a Extractor, Vacuum, Fetal (Class II — Special Controls, product code HDB), submitted by Swift Delivery Products (Oklahoma City, US). The FDA issued a Cleared decision on January 17, 2002, 91 days after receiving the submission on October 18, 2001. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4340.
Device Classification
| Product Code | HDB — Extractor, Vacuum, Fetal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4340 |
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