Percutaneous Transhepatic Cholang. Tray
FDA 510(k) K813335 · American Pharmaseal Div. Ahsc
510(k) numberK813335
Submission
- Device name
- Percutaneous Transhepatic Cholang. Tray
- Applicant
- American Pharmaseal Div. Ahsc
Mchenry, IL, US - Received
- November 24, 1981
- Decision date
- January 8, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FSH – Tray, Surgical, Needle
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FSH
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|---|---|---|---|
| K884876 | S 4 Instrument StandFSH · Traditional | Carl Zeiss, Inc. | 12/15/1988SE |
| K883578 | S 21 Instrument StandFSH · Traditional | Carl Zeiss, Inc. | 09/13/1988SE |
| K821921 | Stand, Surg. Instrument & DressingFSH · Traditional | Emerson-Sack-Warner Corp. | 07/30/1982SE |
| K813338 | Biopsy Needles & TraysFSH · Traditional | American Pharmaseal Div. Ahsc | 01/28/1982SE |
| K813337 | Skinny Chiba Needle & TrayFSH · Traditional | American Pharmaseal Div. Ahsc | 01/28/1982SE |
| K780759 | Model 902 StandFSH · Traditional | Applied Medical Research | 05/19/1978SE |
| K772188 | FSH Ria Kit (125I)FSH · Traditional | Diagnostic Products Corp. | 12/22/1977SE |
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| K872917 | Jinotti Suction/Oxygen Insufflation CatheterBSY · Traditional | 08/11/1987SE |
| K871429 | Antimicrobial Foley CatheterKOD · Traditional | 08/10/1987SE |
| K871770 | American Pharmaseal Wound DressingFRO · Traditional | 06/26/1987SN |
| K870387 | Euromedical, Endosoft Endotracheal TubeBTR · Traditional | 05/08/1987SE |
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Questions and answers
When was Percutaneous Transhepatic Cholang. Tray cleared by the FDA?
Percutaneous Transhepatic Cholang. Tray (K813335) received a 510(k) decision of Substantially Equivalent on January 8, 1982, 45 days after the submission was received.
What is the product code of K813335?
The FDA product code is FSH – Tray, Surgical, Needle, a Class I (low risk) device regulated under 21 CFR 878.4800.