Ksea de la Plaza Blepharoplasty Set
FDA 510(k) K991592 · KARL STORZ Endoscopy-America, Inc.
510(k) numberK991592
Submission
- Device name
- Ksea de la Plaza Blepharoplasty Set
- Applicant
- KARL STORZ Endoscopy-America, Inc.
Culver City, CA, US - Received
- May 7, 1999
- Decision date
- November 2, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HNI – Retractor, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K770222 | Iris RetractorHNI · Traditional | Concept, Inc. | 02/17/1977SE |
More from Concept, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252624 | KARL STORZ Laryngoscopes and AccessoriesEQN · Traditional | 05/15/2026SE |
| K240506 | KARL STORZ HoldersOCV · Traditional | 10/22/2024SE |
| K223885 | HOPKINS TelescopesHIH · Traditional | 09/14/2023SE |
| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP)…GCJ · Traditional | 06/23/2023SE |
| K223520 | UNIDRIVE SIII SystemHIH · Traditional | 04/27/2023SE |
| K223923 | HOPKINS TelescopesGCJ · Traditional | 03/30/2023SE |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF CableFJL · Traditional | 03/17/2023SE |
| K221004 | HOPKINS TelescopesGCJ · Traditional | 12/20/2022SE |
| K222504 | H1GCJ · Traditional | 11/10/2022SE |
| K213194 | HD MediastinoscopeEWY · Traditional | 06/23/2022SE |
Questions and answers
When was Ksea de la Plaza Blepharoplasty Set cleared by the FDA?
Ksea de la Plaza Blepharoplasty Set (K991592) received a 510(k) decision of Substantially Equivalent on November 2, 1999, 179 days after the submission was received.
What is the product code of K991592?
The FDA product code is HNI – Retractor, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.