Suresample-Wallace Endometrial Sampler, Endo 26
FDA 510(k) K001555 · Sims Portex , Ltd.
510(k) numberK001555
Submission
- Device name
- Suresample-Wallace Endometrial Sampler, Endo 26
- Applicant
- Sims Portex , Ltd.
Hythe, Kent, GB - Received
- May 18, 2000
- Decision date
- August 2, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HHK – Curette, Suction, Endometrial (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1175
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Suresample-Wallace Endometrial Sampler, Endo 26 cleared by the FDA?
Suresample-Wallace Endometrial Sampler, Endo 26 (K001555) received a 510(k) decision of Substantially Equivalent on August 2, 2000, 76 days after the submission was received.
What is the product code of K001555?
The FDA product code is HHK – Curette, Suction, Endometrial (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1175.