Suan Flat Dissector Sponges
FDA 510(k) K914082 · Icn Pharmaceuticals, Inc.
510(k) numberK914082
Submission
- Device name
- Suan Flat Dissector Sponges
- Applicant
- Icn Pharmaceuticals, Inc.
Costa Mesa, CA, US - Received
- September 11, 1991
- Decision date
- November 27, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GDY – Gauze/Sponge, Internal, X-Ray Detectable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4450
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972634 | Ultracell Suction SpongeGDY · Traditional | Ultracell Medical Technologies, Inc. | 12/17/1997SE |
| K960236 | CPR Lap SpongesGDY · Traditional | Custom Pack Reliability | 03/28/1996SE |
| K955599 | Stryker Femoral Canal Sponge & Acetabulum SpongeGDY · Traditional | Stryker Corp. | 02/22/1996SE |
| K955322 | Protec X-Ray Detectable Gauze SpongeGDY · Traditional | Derivados DE Gasa, S.A. DE C.V. | 12/19/1995SE |
| K953830 | KensorbGDY · Traditional | Kentron Health Care, Inc. | 10/03/1995SE |
| K953088 | Triangular SpongesGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
| K953087 | Cherry Pit DissectorGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
| K953062 | Cherry DissectorGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
| K953060 | Rosebud DissectorGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
| K953059 | Kittner DissectorGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
More from Medical Perspectives Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K022817 | Cooltouch Nd:Yag Laser System, Model Cooltouch, Cooltouch-Ii Nd:Yag Laser System, Model…GEX · Traditional | 11/22/2002SE |
| K951329 | Immuchem Gal-Mw EaJIA · Traditional | 11/09/1995SE |
| K914530 | Ican GT Drainage BagFRQ · Traditional | 12/18/1991SE |
| K914086 | Ican Cylindrical SpongesGDX · Traditional | 10/09/1991SE |
| K914083 | Ican K Dissector SpongesGDY · Traditional | 10/09/1991SE |
| K914081 | Ican Cotton Rayon BallsFRL · Traditional | 10/09/1991SE |
| K913446 | Ican Needle CountersMMK · Traditional | 09/13/1991SE |
| K904398 | Water Column Relief ValveCAF · Traditional | 07/09/1991SE |
| K770458 | Bilirubin Procedure, Tekpoint Tot & Dir.CIG · Traditional | 05/10/1977SE |
| K770457 | Cholesterol Procedure, Tekpoint TotalCGO · Traditional | 05/03/1977SE |
Questions and answers
When was Suan Flat Dissector Sponges cleared by the FDA?
Suan Flat Dissector Sponges (K914082) received a 510(k) decision of Substantially Equivalent on November 27, 1991, 77 days after the submission was received.
What is the product code of K914082?
The FDA product code is GDY – Gauze/Sponge, Internal, X-Ray Detectable, a Class I (low risk) device regulated under 21 CFR 878.4450.