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FDA 510(k)

SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT

K-Number: K964450 · 1997-01-10

ApplicantPilling Weck Group
Decision Date1997-01-10
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT is the device name listed in this FDA 510(k) record. The listed applicant is Pilling Weck Group. It received FDA 510(k) clearance on 1997-01-10 under 510(k) number K964450. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT?

SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT is a medical device that received FDA 510(k) clearance on 1997-01-10. The listed applicant is Pilling Weck Group. The 510(k) number is K964450.

When did SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT receive FDA 510(k) clearance?

SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT received FDA 510(k) clearance on 1997-01-10, under 510(k) number K964450.

Who is the listed applicant for SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT?

The FDA 510(k) record lists Pilling Weck Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT?

The FDA product code for SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT is HET.

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Other records listing Pilling Weck Group as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971334PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCARK965176PILLING WECK 2 PIECE TAKE-APART INSTRUMENTSK964123REUSABLE TROCAR WITH SLEEVE (COMMON)K963815REUSABLE TROCAR WITH SLEEVE (COMMON)

Related Devices (Code: HET)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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