Houts Hysterectomy Drain
FDA 510(k) K894220 · Helix Medical, Inc.
510(k) numberK894220
Submission
- Device name
- Houts Hysterectomy Drain
- Applicant
- Helix Medical, Inc.
Santa Barbera, CA, US - Received
- June 19, 1989
- Decision date
- August 24, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBW – Catheter, Peritoneal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Houts Hysterectomy Drain cleared by the FDA?
Houts Hysterectomy Drain (K894220) received a 510(k) decision of Substantially Equivalent on August 24, 1989, 66 days after the submission was received.
What is the product code of K894220?
The FDA product code is GBW – Catheter, Peritoneal, a Class I (low risk) device regulated under 21 CFR 878.4200.