The Percutaneous Nephrostolithotomy Drape
FDA 510(k) K851675 · Lingeman Medical Products, Inc.
510(k) numberK851675
Submission
- Device name
- The Percutaneous Nephrostolithotomy Drape
- Applicant
- Lingeman Medical Products, Inc.
Indianapolis, IN, US - Received
- April 23, 1985
- Decision date
- May 14, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EYY – Drape, Urological, Disposable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code EYY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K810291 | Sterile/Disposable HSG TrayEYY · Traditional | Unimar, Inc. | 03/18/1981SE |
Questions and answers
When was The Percutaneous Nephrostolithotomy Drape cleared by the FDA?
The Percutaneous Nephrostolithotomy Drape (K851675) received a 510(k) decision of Substantially Equivalent on May 14, 1985, 21 days after the submission was received.
What is the product code of K851675?
The FDA product code is EYY – Drape, Urological, Disposable, a Class II (moderate risk) device regulated under 21 CFR 878.4370.