Surgairtome Two
FDA 510(k) K781979 · American Sterilizer Co.
510(k) numberK781979
Submission
- Device name
- Surgairtome Two
- Applicant
- American Sterilizer Co.
Mchenry, IL, US - Received
- November 27, 1978
- Decision date
- December 20, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HSZ – Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HSZ
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|---|---|---|---|
| K991588 | EMS Swiss OrthoclastHSZ · Traditional | (Ems Sa) Electro Medical Systems | 07/21/1999SE |
| K972860 | Curvtek TSR SystemHSZ · Traditional | Biolectron, Inc. | 10/31/1997SE |
| K970345 | Alignment InstrumentHSZ · Traditional | Richard Wolf Medical Instruments Corp. | 04/29/1997SE |
| K955084 | Aspach 65,000 (Modification)HSZ · Traditional | The Anspach Effort, Inc. | 01/17/1996SE |
| K954080 | Sodem High Speed SystemHSZ · Traditional | Sodem Diffusion SA | 10/16/1995SE |
| K944590 | Ethicon Drill Bit and Drill GuideHSZ · Traditional | ETHICON, Inc. | 05/11/1995SE |
| K934336 | SpinalplaneHSZ · Traditional | Synvasive Technology, Inc. | 03/10/1995SN |
| K940276 | Filter, DiffuserHSZ · Traditional | Anspach Mfg., Inc. | 11/16/1994SE |
| K942760 | Pneumatic Wire TensionerHSZ · Traditional | Smith & Nephew Richards, Inc. | 09/06/1994SE |
| K941681 | Arthrex Circular Harvesting SawHSZ · Traditional | Arthrex, Inc. | 08/25/1994SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943288 | Amsco SQ240 Surgical LightFSY · Traditional | 10/17/1994SE |
| K931872 | The Eagle 3017 100% Ethylene Oxide SterilizerFLF · Traditional | 02/07/1994SE |
| K922485 | Chemdi-Vhp Chemical IndicatorJOJ · Traditional | 09/29/1993SE |
| K930493 | Quantum 3080 Surgical TableFQO · Traditional | 06/22/1993SE |
| K905816 | Orthovision TableJEB · Traditional | 03/06/1991SE |
| K896674 | Amsco Quantum LightFSY · Traditional | 01/03/1990SE |
| K895164 | Eagle DSECG · Traditional | 11/17/1989SE |
| K882660 | General Surgical Table and AccessoriesFQO · Traditional | 07/25/1988SE |
| K880198 | Gemini Surgical LightFSS · Traditional | 02/10/1988SE |
| K864846 | Radiographic - Leg SectionKQS · Traditional | 12/24/1986SE |
Questions and answers
When was Surgairtome Two cleared by the FDA?
Surgairtome Two (K781979) received a 510(k) decision of Substantially Equivalent on December 20, 1978, 23 days after the submission was received.
What is the product code of K781979?
The FDA product code is HSZ – Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.