POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE
Device Facts
| Record ID | K910252 |
|---|---|
| Device Name | POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE |
| Applicant | CooperSurgical, Inc. |
| Product Code | HEE · Obstetrics/Gynecology |
| Decision Date | Mar 4, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5100 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An obstetric anesthesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.
